Omnaris eent

Name: Omnaris eent

Uses for Omnaris

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.1 2 6

Generally provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and nasal itching.1 3 7

Omnaris Pharmacokinetics

Absorption

Bioavailability

Systemic absorption <1% following intranasal administration of recommended doses in adults.1 3 6 7

Children 6–11 years of age: Des–ciclesonide detected in serum of 50% receiving recommended intranasal dosages.1

Onset

24–48 hours in adults and children ≥12 years of age;1 2 4 5 further symptomatic improvement occurs in 1–2 weeks in seasonal allergic rhinitis and 5 weeks in perennial allergic rhinitis.1 2

Distribution

Plasma Protein Binding

≥99% (mainly albumin and α1-acid glycoprotein).1 3

Extent

Distributed into milk in rats; not known whether distributed into human milk.1

Elimination

Metabolism

Prodrug; hydrolyzed by nasal mucosa esterases to active metabolite des-ciclesonide.1 Des-ciclesonide metabolized by CYP3A4 and to a lesser extent, by CYP2D6.1 3

Elimination Route

Following IV administration, excreted in feces (approximately 66%) and in urine (≤20%).1

Half-life

Des-ciclesonide IV: 2.7 hours.9

Des-ciclesonide oral: 5.9 hours.9

Special Populations

Hepatic impairment increases systemic exposure by 1.4–2.7-fold following oral inhalation.1

Stability

Storage

Intranasal Inhalation

Nasal Spray

25°C (may be exposed to 15–30°C).1 Do not freeze.1

After removal from foil pouch, discard after 4 months or 120 sprays following priming.1

Actions

  • Glucocorticoid.1 Prodrug.1 Hydrolyzed to active metabolite, des-ciclesonide; 1 3 4 5 6 7 8 affinity of des-ciclesonide for glucocorticoid receptors 120 times that of the parent compound.1 3

  • Wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic inflammation.1 3

  • May alter adrenal function in pediatric patients;1 effects on adrenal function in adults and adolescents not established.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ciclesonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension, for intranasal use only

50 mcg/metered spray

Omnaris

Sepracor

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